Patient's compliance with a prescribed therapeutic regimen can have a direct impact on the overall management of illness and clinical outcome, and, therefore, the improvements with regimen compliance will improve patient's health and reduce costs, both financial and physical associated with the therapeutic process. According to the data provided by the U.S. Department of Health and Human Services, diabetes affects over 25 million people in the US alone (National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, Ga.: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011), with, as estimated, 80 million people exhibiting signs of prediabetes. Though a strict adherence to diet, exercise, and drug regimens the diabetes sufferers can manage the symptoms associated with the disease indefinitely. Non-compliance to the insulin regimen is a significant problem for patients and health care professionals alike, and can exasperate the diabetes progression, with the unwanted results such as poor metabolic control, hospitalization for diabetes ketoacidosis, limb amputation, hyperosmolar coma, or even more detrimental consequences.
Because regimen compliance has been shown to be such a problem with patients and have such a significant impact on disease progression or presentation, many attempts have been made over the years to understand why patients have problems adhering to a regimen and how adherence can be improved. Furthermore, non-compliance to research study regimens significantly reduces the power and efficacy of clinical studies as an average compliance of 50% vs 100% requires an increase in sample size by fivefold to retain the sample study power. Thus having an accurate understanding of a patient's regimen compliance can help determine if a drug or therapeutic regimen is not working due to incorrect adherence or if an alternate regimen needs to be implemented by the physician. Unfortunately, understanding a patient's regimen compliance is difficult as patients often overestimate (incorrectly estimate) their adherence and multiple studies have found clinicians assessments of patient compliance to be unreliable.
Ideas for improving regimen compliance range from improving the doctor-patient relationship to improving patient oversight to improving patient health beliefs and providing education to patients regarding their disease. While each of these interventions has been studied, oversight is a major concern as over 95% of diabetic patients administering their own care, and regimen oversight has shown to significantly improve adherence. Accordingly, there remains a need for a system to document exactly how much medication delivered from a fluid filled container (for example, a syringe) actually gets into the delivery site (such as a patient's tissue), and according to which schedule such drug administration is carried out.
Eye-drop medications, both prescription and over-the-counter (OTC), are a mainstay of therapy for treating ocular complications. Eye drops are generally a preferred method of treatment because they are effective, substantially non-invasive, have limited systemic absorption and side effects compared to oral or intravenous medication administration, and in theory are easy to use. However, there is concern among ophthalmologists regarding the use of eye drops. Specifically, recent studies have found that compliance to eye-drop regimens is much lower than expected. This results in suboptimal therapeutic levels, which can reduce the efficacy of treatment. When eye drops are administered in a physician's clinic, trained technicians perform the procedure correctly; however, when eye drops are administered by patients (so called self-administration of treatment) they are not always administered correctly. The patient self-administering eye-drops does not always follow the procedural standards for drop administration and/or the proper timing for drop administration (for example for a twice a day regimen, the drops are not administered at 8 AM and 8 PM), which results in incorrect dosing. Even in cases where a clinician instructs a patient and/or asks a patient direct questions regarding an eye-drop regimen, or even when electronic monitoring of the procedure in employed, it is currently not possible to know if the drop intended for the eye actually got into the patient's eye or if they end up on the patients lid or if more than one drop was delivered into the eye. While some reasons for failed compliance are unavoidable, some of the causes (such as forgetfulness, confusion of similarly looking eye-drop containers or just plain error as to which eye drops to use, as well as failure to correctly follow an eye-drop administering procedure) are correctable.
Several devices have been developed to help patients adhere to eye-drop administering regimens. A system referred to as Travalert (manufactured by Alcon, Inc., Ft. Worth, Tex.), for example, utilizes electronic recording for unbiased, reliable measurements of instillation times and eye-drop counts. Other systems utilize timers and alarms to remind a patient that it is time to apply the eye drop(s) or weight measuring devices to ensure that medication has been removed from the bottle. Neither of these techniques for monitoring compliance with a procedure is meant to directly determine if and/or how much of the drop medication actually gets delivered to the patients eye(s). Instead, measurements performed by such systems are those of whether a patient attempts to administer the eye drops.
A study using video monitoring of eye-drop application has found that of subjects claiming not to miss an eye (when delivering eye-drops), nearly one third actually missed it and that out of all subjects using eye drops, approximately one third could not administer a drop onto the eye at all. Another study found that only about 9% of patients are able to correctly self-administer eye drops. Thus, even if patients are reminded about taking their eye drop medication and even if they have a scale for measuring dispensation of the eye drops, it is still not known if they drops ever make it into the eye or just land on the patients lids, cheek or other area outside the eye. It is also not known if the appropriate amount of medication finds its way into their eyes. Some patients waste copious amounts of eye drops trying to get the medication into their eyes and end up with too much or too little in their eye(s). Accordingly, there remains a need for a system to document exactly how much of a medication delivered from a fluid filled bottle, for example an eye-drop bottle, actually gets into the site it is to be delivered into, which for eye drops would be the patient's eye. There is also a need to a system that help patients understand how they are applying the drops, so that they can be educated on what changes need to be made to achieve the proper delivery of the drops/medication to their eye. Such a system should improve the management of ocular diseases, and should help to save health care costs by reducing the amount of drops wasted. In operation, for example, such a system provides an assessment of how much drug was delivered into the eye and provides an output based on which a better correlation can be defined of side effects (such as an irritation, for example, developed as a function of the volume of delivered drug) that a patient has from the drug to their application and application process. The system would allow for correlation of effects produced on an eye-lid as a function of a number of drops that get on the lid (instead of an eye) to better identify factors that lead to side effects and develop strategies for mitigation of such effects.